The Food and Drugs Administration (FDA) continued to find itself in hot water following what consumer groups viewed as a flawed and biased virtual public consultation on the guidelines for e-cigarettes and heated tobacco products (HTPs) last week.
This surfaced in the wake of calls for a full-blown House investigation on the FDA following the admission of the agency that it received funding from international anti-tobacco groups.
“The supposed consultations held by FDA on October 6 and October 8 on vapor products and heated tobacco products, respectively, turned out to be a one-sided, pre-recorded lectures with cherry-picked questions that ignored the concerns of vapers, skipped scientific evidence, and violated the rights of consumers to be heard,” said Clarisse Virgino, Philippine representative to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
"The imposed limitations during the public consultation made it challenging to discuss extensively and thoroughly the crucial provisions of the proposed guidelines. In coming up with a regulation that has the potential to positively change the lives of 16 million Filipino smokers, we, the stakeholders, were expecting a more transparent and participatory process," Peter Paul Dator of Vapers PH said.
He said “all we ask for are transparency and inclusion in the discussion because we—the consumers—are the ones directly affected by these guidelines, and not the pharmaceutical or medical groups who have no stake in the issue.”
Several stakeholders invited to the public consultation took the FDA to task for its “quit or die” approach to regulation and warned that those already using these alternatives are at risk of going back to smoking cigarettes.
They also slammed the FDA for drafting very restrictive regulatory guidelines that may serve as de-facto ban on vapes and HTPs.
“E-cigarettes and heated tobacco products are not pharmaceutical products and should not be regulated as such. What we need is a fair and risk-proportionate regulation that will encourage smokers to reduce their exposure to smoke which is the one that causes all these diseases,” Virgino said.
During the public consultation last October 8, Nueva Ecija Rep. EstrellitaSuansing exposed the grant received by the FDA from foreign anti-tobacco groups The Union and Bloomberg Initiative raising questions on possible conflict of interest on the part of the agency. This prompted Deputy Speaker and Ilocus Sur Rep. Deogracias Victor Savellano to call for a congressional investigation on the matter.
The FDA conducted two public hearings as it prepares the guidelines for the regulation of vape products and HTPs, which the Royal College of Physicians, Public Health England, and the National Academies of Science, Engineering and Medicine recognize as presenting better alternatives to conventional smoking because they eliminate the combustion process that releases 7,000 chemicals.
“We hope that in the next dialogues, if there are any, the FDA officials will open their minds, listen to scientific evidence, and do their job of regulating, and not restricting the use of these novel products, as our existing laws intended," Dator said.